For the use only of an Oncologist or a Rheumatologist or a Hospital or a Laboratory

TM

(Rituximab Injection)

100 - 200

Page 1 of 10

TM

100Each 10 mL vial contains Rituximab (r DNA origin) 100 mg

TM

500Each 50 mL vial contains Rituximab (r DNA origin) 500 mg

Version No : 1

PANTONE CODES

Black C

423 C

Dimensions : LxW (100-200 mm)

TM

150021937

Version No : 1

PANTONE CODES

Black C

423 C

Dimensions : LxW (100-200 mm)

Page 2 of 10TM

150021937

Page 3 of 10

Version No : 1

PANTONE CODES

Black C

423 C

Dimensions : LxW (100-200 mm)

TM

150021937

Others reported <5% were:- bodypain (4.2%), flushing (4.2%), chest pain (2.2%), malaise (2.0%), tumour pain (1.7%), cold syndrome (1.4%), neck pain (1.1%), hypertension(4.5%), tachycardia (1.4%), arrhythmia (1.4%), orthostatic hypotension (1.1%), diarrhoea (4.2%), dyspepsia (2.8%), anorexia (2.8%), dysphagia (1.4%), stomatitis (1.4%), constipation (1.1%), anaemia (3.7%), peripheral oedema (4.8%), LDH increase (2.2%), hypocalcaemia (2.2%), facial oedema (1.1%), weight decrease (1.1%), hypertonia (1.4%), pain (musculoskeletal) (1.1%), insomnia (2.2%), vasodilatation (1.7%), hypoaesthesia (1.4%), agitation (1.4%), dyspnoea (2.2%), chest pain (1.1%), respiratory disease (1.1%), night sweats (2.8%), sweating (2.8%), lacrimation disorder (3.1%), conjunctivitis (1.4%), ear pain (1.1%), tinnitus (1.1%).

The following adverse events were reported in < 1 %: coagulation disorders, asthma, lung disorder, bronchiolitis obliterans, hypoxia, abdominal enlargement, pain at the infusion site, bradycardia, lymphadenopathy, nervousness, depression, dysgeusia.

Body systemAdverse event

All grades % Grade 3 and 4 %

Any adverse event 91.0 17.7

Body as a whole

Fever 48.3 0.6

Chills 31.7 2.2

Asthenia 18.0 0.3

Headache 12.6 0.6

Throat irritation 7.6 -

Abdominal pain 7.0 0.6

Cardiovascular system

Hypotension 9.8 0.8

Digestive system

Nausea 17.1 0.3

Vomiting 6.7 0.3

Blood and lymphatic system

Leucopenia 12.4 2.8

Neutropenia 11.2 4.2

Thrombocytopenia 9.6 1.7

Metabolic and nutritional disorders

Angioedema 10.7 0.3

Hyperglycaemia 5.3 0.3

Musculoskeletal system

Myalgia 8.1 0.3

Arthralgia 5.9 0.6

Nervous system

Dizziness 7.3

Respiratory system

Bronchospasm 7.9 1.4

Rhinitis 7.3 0.3

Increased cough 5.1 0.3

Skin and appendages

Pruritus 12.4 0.3

Rash 11.2 0.3

Urticaria 7.3 0.8

Page 4 of 10

Version No : 1

PANTONE CODES

Black C

423 C

Dimensions : LxW (100-200 mm)

TM

150021937

System Organ ClassAdverse event

Incidence N (%)

CHOP R-CHOP

Any adverse event 152 (67) 185 (79)

Gastrointestinal disorders

Nausea 9 (4) 13 (6)

Vomiting 8 (4) 7 (3)

Diarrhoea 5 (2) 6 (3)

Abdominal pain 6 (3) 4 (2)

Page 5 of 10

Version No : 1

PANTONE CODES

Black C

423 C

Dimensions : LxW (100-200 mm)

TM

150021937